Bio-Rad Laboratories has launched its SARS-CoV-2 Total Ab test, a blood-based immunoassay kit to help determine if an individual has developed antibodies to SARS-CoV-2, the virus associated with COVID-19 disease. Bio-Rad has applied for Emergency Use Authorization offered by the U.S. Food and Drug Administration and has met the CE mark requirements for Europe.
Bio-Rad’s SARS-CoV-2 Total Ab test can help clinicians identify if an individual has been infected by SARS-CoV-2 and therefore has developed an immune response against the virus. The test detects IgG, IgM, and IgA antibodies, an approach that appears to be more sensitive than assays against a single immunoglobulin.1 Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
Broad-based antibody testing can provide a more complete picture of infection rates and immunity to help public health officials in their efforts to reduce containment orders.
“We are pleased to introduce our SARS-CoV-2 Total Ab test to support COVID-19 diagnosis and population screening,” said Dara Wright, clinical diagnostics group president, Bio-Rad. “Having applied for FDA Emergency Use Authorization and meeting the requirements for CE marking, we have begun shipping the test and are in the process of scaling up manufacturing to meet demand in the weeks and months ahead,” she said.
The SARS-CoV-2 Total Ab test can be used manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.
